- GW Pharma (GWPH +0.8%) initiates a Phase 3 study evaluating two doses of Epidiolex (cannabidiol), 10 mg/kg and 20 mg/kg, and placebo in patients with Dravet syndrome, a rare and catastrophic form of childhood epilepsy. The 14-week trial will enroll 150 patients (50 patients per arm). The primary endpoint is the percentage change from baseline in convulsive seizure frequency during the maintenance period compared to placebo. Following the trial, all patients will be eligible to receive Epidiolex under a long-term open label extension study.
- Patient enrollment should be completed this year followed by top-line results in early 2016. The company expects to file its New Drug Application (NDA) with the FDA in mid-2016.
- Previously: GW Pharma initiates Phase 3 study of Epidiolex in Dravet syndrome (March 31)